This invention will be particularly discussed in relation to deployment devices for placement of stent grafts into the thoracoabdominal aorta for the treatment of aneurysms and more specifically in relation to juxtarenal placement. The invention, however, is not so restricted and may be applied to stent grafts for placement in any lumen of the human or animal body.
Surgical repair of the thoracoabdominal aorta often involves wide exposure through long, multi-cavity incisions, followed by periods of visceral ischemia. Despite advances in surgical technique and perioperative care, the mortality and morbidity rates remain high, especially in patients who are old, sick, or have already undergone open surgical repair of an adjacent segment of the aorta. In such cases, an endovascular alternative would be welcome, yet endovascular methods of thoracoabdominal and pararenal aortic repair have been slow to develop. The challenge has been to exclude the aortic aneurysm while maintaining flow to its visceral branches.
Two distinctly different approaches to this problem have been reported. The two devices were: a bifurcated abdominal aortic stent-graft with fenestrations for the renal and superior mesenteric arteries, and a thoracoabdominal stent-graft with branches for the celiac, superior mesenteric and renal arteries. In recent years, the distinctions between fenestrated and multi-branched stent-grafts have been bluffed by the emergence of many hybrid devices with features such as Nitinol ringed fenestrations, externally cuffed fenestrations, internally cuffed fenestrations, external spiral cuffs and axially-oriented cuffs or branches, both external and internal. Each element has advantages and disadvantages, and each combination has a different role, as described below.
There now exists a family of devices for treatment of abdominal aortic aneurysms (AAA), which share several key features. In each of them, a barbed uncovered Z-stent anchors the proximal end, and a single proximal orifice attaches to a non-dilated segment of aorta (or previously inserted prosthesis). They all distribute blood through multiple branches, cuffs or holes (fenestrations), and they have series of Z-stents and Nitinol rings, providing support from one end of the stent-graft to the other.
In cases of juxtarenal AAA, the rim of non-dilated infrarenal aorta is too short for secure hemostatic implantation of an unfenestrated stent-graft. There is only enough room in the neck for the proximal end of the proximal stent; the rest of this covered stent expands into the aneurysm, assuming a conical shape. Under these circumstances, there is insufficient apposition between the stent-graft and the aorta to achieve a reliable seal. Properly positioned fenestrations (holes) provide a route for flow through the stent-graft into the renal arteries, thereby allowing the proximal end of the stent-graft to be placed higher in the non-dilated pararenal aorta where it assumes a cylindrical shape. The dual goals of renal perfusion and aneurysm exclusion are achieved only when the fenestration is positioned precisely over the renal orifices, and the outer surface of the stent-graft around the fenestration is brought into close apposition with the inner surface of the aorta around the renal orifice. Typical fenestrated technique uses a bridging catheter, sheath or balloon to guide each fenestration to the corresponding renal orifice, and a bridging stent to hold it there. Stent-graft deployment has five main stages: extrusion of the half-open stent-graft, trans-graft renal artery catheterization, complete stent-graft expansion, renal stenting, and completion of the aortic exclusion with bifurcated extension into the iliac arteries.
The three forms of fenestration in common use are the large fenestration, the scallop and the small fenestration. A large fenestration is used only when the target artery is well away from the aneurysm. No bridging stent is required, or even feasible, since one or more stent struts cross the orifice of a large fenestration. A scallop is essentially a large open-topped fenestration. In many cases, the presence of a scallop for the superior mesenteric artery allows sufficient separation (>15 mm) between proximal margin of the stent-graft and the middle of the renal orifices. Small fenestrations are commonly placed over both renal arteries, and held there by bridging stents. Stent struts cannot cross the orifice of a small fenestration. Small fenestrations are therefore confined to the lower halves of the triangular spaces between adjacent stent-struts.
Localized juxtarenal aneurysms or pseudoaneurysms require no more than a single cylindrical fenestrated stent-graft, but most cases of infrarenal aneurysm extend to the aortic bifurcation and require bilateral iliac outflow through a bifurcated stent-graft. The combination of a fenestrated proximal component with a bifurcated distal component is called a composite stent graft. Dividing the stent-graft into two components separates the two halves of the procedure. The operator need not be concerned about the position or orientation of the bifurcation while inserting the fenestrated proximal component, or about the position and location of the fenestrations while inserting the bifurcated distal component. The composite arrangement also separates the fenestrated proximal component from the large caudally directed haemodynamic forces that act mainly upon the bifurcation of the distal component. A small amount of slippage between the two is preferable to any proximal component migration, where even a few millimetres of movement would occlude both renal arteries. Indeed, the low rate of renal artery loss is testimony to the accuracy of stent-graft deployment and the stability of stent-graft attachment.
It is to the problem of trans-graft renal artery catheterization for subsequent renal stenting that the present invention is directed. The invention will be discussed in relation to renal catheterisation but is not so limited.
There can be a problem with placement of a guide wire or catheter through a fenestration and into a renal artery. It can be assisted by pre-catheterisation of the fenestration or fenestrations but the presence of an auxiliary catheter can be a problem. The final stage of stenting a renal artery cannot be achieved until the main body of a deployment device has been removed but the presence of an auxiliary catheter can make this difficult.
It is to this problem that the present invention is directed.
Throughout this specification the term distal with respect to a portion of the aorta, a deployment device or a prosthesis means the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart. When applied to other vessels similar terms such as caudal and cranial should be understood.